Welcome to Avalis Publishing
Since 2008, the Avalis team has provided exceptional Regulatory Operations support for biotech and pharmaceutical companies throughout all phases of the drug development and marketing process.
We offer strategic electronic publishing and eCTD submission expertise that is based on the principles of quality, compliance and purpose.
About Us
Founding partners, Lisa Johnson and Alison Moraska, have worked together in managing and producing in excess of 7,000 eCTD submissions to US, EU and CA Regulatory Authorities. These submissions range from pre-IND meeting materials through original DMF, IND/CTA, NDA, BLA and ANDA applications and ensuing maintenance and post-approval support. We pride ourselves on our ability to construct submissions that accurately represent the unique development of each product, with the utmost goal of delivering high-quality, reviewer-friendly dossiers throughout the entire regulatory application lifecycle.
